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Cocoa Flavanols and Painfree Walking Distance

NCT ID: NCT01064583

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-12-31

Brief Summary

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To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.

Detailed Description

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62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled.

Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days.

The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion

Conditions

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Peripheral Artery Disease Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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flavanol rich cocoa drink (596mg)

dissolved in water, twice daily intervention

Group Type EXPERIMENTAL

cocoa

Intervention Type OTHER

dissolved in water twice-daily intervention

flavanol poor cocoa drink ( 13mg)

dissolved in water, twice daily intervention

Group Type EXPERIMENTAL

cocoa

Intervention Type OTHER

dissolved in water twice-daily intervention

Interventions

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cocoa

dissolved in water twice-daily intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* peripheral artery disease (Fontaine IIb)
* diabetes mellitus
* \> 18 years

Exclusion Criteria

* acute and terminal renal failure
* acute infection
* heart failure (NYHA III-IV)
* arrhythmias
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Heiss, MD

Role: PRINCIPAL_INVESTIGATOR

Heinrich Heine University

Malte Kelm, MD

Role: STUDY_CHAIR

Heinrich Heine University

Locations

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Heinrich Heine University

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Related Links

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http://www.uniklinik-duesseldorf.de/kardiologie

Related Info

Other Identifiers

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Flavanols-PAD

Identifier Type: -

Identifier Source: org_study_id